FDA Approves OxyContin For Extremely Ill Children

OxyContin pills

File – OxyContin pills are arranged for a photo at a pharmacy in Montpelier, Vt. on Tuesday, Feb. 19, 2013. | Toby Talbot / AP

The U.S. Food and Drug Administration (FDA) approved the narcotic painkiller OxyContin for pediatric use in children ages 11 to 16 with chronic pain that cannot be treated successfully with other medications.

OxyContin is an extended-release version of the opioid, oxycodone.  Physicians have been prescribing OxyContin to children for some time but without the safety and efficacy data.

The approval is for children 11 and older who are already tolerating a minimum daily dose of at least 20 milligrams per day. The agency says that with extended-release OxyContin, a child may require two doses a day, versus four to six of the immediate-release version of the drug.

The FDA does not regulate the practice of medicine, which means drugs such of OxyContin may be prescribed for off-label use to children once a caregiver has provided consent.

The approval comes after Purdue Pharma, the drug’s manufacturer, submitted data to the agency that indicates the drug is safe for children if used correctly.

Purdue Pharma’s reputation was tarnished after three of the company’s top executives pleaded guilty to misleading doctors, regulators and the public about OxyContin’s addiction risk in 2007. Purdue Pharma L.P.; Michael Friedman, president; Howard R. Udell ,top lawyer; and Dr. Paul D. Goldenheim, former chief medical officer agreed to pay $634.5 million in fines and other payments, one of the largest amounts ever paid by a drug company in such a case.

Following the trial, the FDA banned the original OxyContin formula and in 2010, the company developed an uncrushable tablet that was more difficult to snort or inject than the original.

Experts blame the rise of prescription painkiller use in the United States for the nation’s current heroin epidemic.

According to the Center for Behavioral Health Statistics and Quality, four out of five new heroin users abused prescription painkillers first.

Dr. Sharon Hertz, director of the division of anesthesia, analgesia and addiction products at the Office of New Drugs, part of the FDA’s Center for Drug Evaluation and Research, said prior to this review, physicians have had to rely on safety and efficacy data from studies of the drug in adults, and it was uncertain if this data is an accurate predictor of the effects the drug may have on children.

Hertz explaines on the FDA website, OxyContin comes with the same level of risks for children as adults, as long as the drug is used under strict supervision by a physician and caregiver. She said it’s important for parents and physicians to make sure a child understands the potential risks that may arise from the drug and how to use it safely. Likewise, parents should be educated by health care professionals on what to watch out for, such as whether a child asks for more of the drug beyond the amount prescribed.

“Parents and caregivers should follow all the usual safeguards for storing powerful medications when OxyContin is in their home.”